FDA Researchers Highlight Imaging Tech to Speed Complex Generics

Advanced imaging technologies could help generic drug manufacturers overcome longstanding challenges in demonstrating bioequivalence for complex drug products, potentially reducing reliance on costly comparative clinical endpoint studies, according to a new journal article by FDA researchers.

Their review, published in a recent issue of Biophotonics Discovery, examines how modern imaging techniques can improve the characterization of complex drug formulations, establish relationships between product structure and performance, and measure drug availability at local sites of action.

The six authors from CDER’s Office of Generic Drugs, identified five major research areas: detailed characterization of complex drug structures; understanding how structural features influence product performance; noninvasive measurement of drug bioavailability; application of artificial intelligence and machine learning to imaging data; and development of mechanistic insights to support computational modeling.

Complex generic products present particular regulatory challenges because conventional bioequivalence methods may not adequately characterize their structural properties or demonstrate comparable drug delivery and performance, the authors wrote.

The researchers found that imaging technologies can provide nondestructive characterization of complex formulations, establish relationships between product structure and function, and directly measure drug availability at sites of action. These capabilities could support more efficient, scientifically rigorous bioequivalence assessments and reduce the need for expensive clinical endpoint studies traditionally used to establish therapeutic equivalence, the researchers said.

“However,” they wrote, “to realize their full potential, these technologies ideally need to be incorporated into commercially available instruments with capabilities that are optimized for the study designs needed in pharmaceutical product research and development and for regulatory decision-making. These capabilities include substantially reduced acquisition times, better spatial resolution, automated high-throughput sample analysis, integrated and validated data processing, and user-friendly software interfaces.”